CA-800 Corneal Analyzer

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Grant Parks
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1 CA-800 Corneal Analyzer

CA-800 - Fully featured Ease of use The CA-800 is extremely easy to handle and use. From image acquisition to analysis, the on-board software is intuitive and user-friendly and the 10.

2 CA Fully featured Ease of use The CA-800 is extremely easy to handle and use. From image acquisition to analysis, the on-board software is intuitive and user-friendly and the 10.1 inch capacitive touch screen provides quick navigation. Visual guidance supports fast and easy alignment and focusing on the eye; the best image selection mode automatically acquires the best-focused image. The CA-800 is a placido-based topography system that delivers accurate, high resolution images of the anterior corneal surface. The keratoscope cone with 24 rings equally spaced on a 43D sphere analyses over 100,000 data points with axial and instantaneous curvature evaluation. Integrated PC The compact design of the CA-800 includes a fully integrated PC, so that an external PC is not required to manage a patient database, for archiving and re-analysis purposes. The patient database is stored on an internal 320 GB SATA hard disk and the CA-800 includes a 32 GB SSD for a quick start up of the instrument and user interface. 2

CA-800 - Corneal Analyzer Accurate, full examination of the anterior corneal surface CA-800 fully featured Topography map Map full screen mode Ring editing Keratoconus screening (KPI) Full 3D map of

Differential map Post-operative monitoring of corneal healing Pupillometry Automated pupil recognition Dynamic, Photopic, Mesopic & Scotopic Latency graph Real time fluorescein acquisition and

3 CA Corneal Analyzer Accurate, full examination of the anterior corneal surface CA-800 fully featured Topography map Map full screen mode Ring editing Keratoconus screening (KPI) Full 3D map of corneal surface Automated best image selection OD/OS results on same screen Corneal wavefront (Zernike) analysis Corneal surface height map Comparison map Reviewing of previous patient examinations Differential map Post-operative monitoring of corneal healing Pupillometry Automated pupil recognition Dynamic, Photopic, Mesopic & Scotopic Latency graph Real time fluorescein acquisition and imaging Internal yellow barrier filter White to white measurement Meibomian gland analysis Tear film breakup time analysis Contact lens fitting simulation Complete contact lens fitting software Contact lens database on-board Toric IOL calculation Oculentis 10.1 inch Capacitive touch screen Fully integrated patient database DICOM Compliance IMAGENET 6 Compliance 3

All features accessible on just one screen 1 13 17 12 2 14 15 18 3 4 5 6 7 16 19 8 9 10 11 20 19 21 Patient database & acquisition 1 11 Topography 2 12 ODS on one screen 3 13 Aberrometry 4 14 Height

4 All features accessible on just one screen Patient database & acquisition 1 11 Topography 2 12 ODS on one screen 3 13 Aberrometry 4 14 Height map 5 15 Comparison & differential map 6 16 Pupillometry 7 17 Fluorescein imaging 8 18 White to white 9 19 Tear film breakup time Patient ID IOL calculation & contact lens fitting Keratometry & indices Keratoconus screening Ring editing Report printing 3D map Display options 10 Meibography 20 Full screen mode 21 Display options 4

CA-800 - Corneal Analyzer Acquisition The CA-800 is easy to use. Visual signals support fast and easy alignment and focusing on the patients eye.

The automated best image selection mode in the software of the CA-800 decides the best focused position and automatically acquires the image.

Keratoconus screening With the CA-800, signs of asymmetry of the cornea can easily be detected even in an early stage.

5 CA Corneal Analyzer Acquisition The CA-800 is easy to use. Visual signals support fast and easy alignment and focusing on the patients eye. The CA-800 has a right and left eye detection and prevents incorrect savings in right/left eye measurements. The automated best image selection mode in the software of the CA-800 decides the best focused position and automatically acquires the image. Acquisitions can be made for topography, pupillometry and real time fluorescein imaging. Keratoconus screening With the CA-800, signs of asymmetry of the cornea can easily be detected even in an early stage. By analyzing the apical curvature, apical gradient and symmetry of the cornea, a Keratoconus probability index will show in color code (green, yellow & red) if the topography is com pa tible with Keratoconus. With the CLMI (Cone Location and Magnitude Index) it is easy to followup on Keratoconus and Keratoconus-like patterns. Corneal Zernike analysis The Zernike analysis module consists of 36 polynomials into the 7th order, and provides a clear view on the optical deficiencies which can disturb vision. Based on this information, the CA-800 provides the visual acuity summary. Zernike analysis is the basis for the calculation of the ablation area for laser treatment. The Zernike expansion coefficient is used to determine which component(s) dominate the aberration structure of the cornea and to what degree. 5

$follow up and for pre- and postoperative corneal analysis. With the differential map, progress in recovery of the cornea can be observed after refractive surgery.$ Parameters such as keratometry, apical curvature and corneal symmetry can be analyzed to follow the development of any corneal surface changes.

Parameters such as keratometry, apical curvature and corneal symmetry can be analyzed to follow the development of any corneal surface changes.

Pupillometry The CA-800 is equipped with two white LED s for dynamic and static pupillometry.

$refractive surgery treatments. Dynamic pupillometry provides clear information on the reaction time of the pupil and the contraction of the pupil.$

6 All features accessible on just one screen Corneal comparison & differential map With the CA-800, it is easy to compare topography maps between two examinations of a patient, which can be used for follow up and for pre- and postoperative corneal analysis. With the differential map, progress in recovery of the cornea can be observed after refractive surgery. Parameters such as keratometry, apical curvature and corneal symmetry can be analyzed to follow the development of any corneal surface changes. The CA-800 comparison and differential maps help you with the treatment of collagen cross linking to stop the development of corneal keratoconus. Pupillometry The CA-800 is equipped with two white LED s for dynamic and static pupillometry. With the CA-800 on-board, the user can check the pupil position and diameter (from Photopic to Scotopic condition) in relation to the position of the optical zone in Ortho-K, laser treatment or refractive surgery treatments. Dynamic pupillometry provides clear information on the reaction time of the pupil and the contraction of the pupil. Fluorometry The CA-800 incorporates eight blue LED s for fluorescein images and real time fluorescein videos which are essential for contact lens fitting. During every measurement the CA-800 automatically registers the pupil diameter, which is critical information during contact lens fitting. Real time fluorescein films allow the eye care practitioner to judge the movement of the contact lens on the cornea, the distribution of the tear film under the contact lens as well as the wetting of the outer contact lens surface. The corneal condition can be observed by recording a real time fluo film without wearing a contact lens. The tear film condition, corneal artifacts and break up tear time (BUT) can be observed. 6

CA-800 - Corneal Analyzer Meibomian gland analysis With the infra-red

lower eyelid can be captured and analyzed.

MGD (Meibomian Gland Dysfunction) can cause or exacerbate dry eye

The oil glands become blocked with thickened secretions.

which results in permanent changes in the tear film and dry eyes.

Meibomian gland examinations of the patient.

the best fitting contact lens based upon an included complete contact

$With the option to input refractive powers, the contact lens proposal$

7 CA Corneal Analyzer Meibomian gland analysis With the infra-red illumination of the CA-800, the Meibomian Glands of the upper and lower eyelid can be captured and analyzed. Posterior blepharitis is the most common form of lid margin disease. MGD (Meibomian Gland Dysfunction) can cause or exacerbate dry eye symptoms and eyelid inflammation. The oil glands become blocked with thickened secretions. Chronically clogged glands eventually become unable to secrete oil which results in permanent changes in the tear film and dry eyes. With the CA-800, MGD can easily be observed and compared with previous Meibomian gland examinations of the patient. Contact lens fitting simulation The CA-800 provides the perfect platform for contact lens fitting. Simulation software is provided on-board, which automatically selects the best fitting contact lens based upon an included complete contact lens database for all the main manufacturers (upgradable and customizable by the user). With the option to input refractive powers, the contact lens proposal is accurate and complete. The on-board fluorescein acquisition system allows full control of the contact lens position on the eye. The comparison between different contact lenses is easy in order to ensure the best fit. 7

All features accessible on just one screen Tear film breakup time analysis Dry eye syndrome is a growing public health concern causing visual disturbance due to tear film instability.

Blink detection The Blink detection records the patient blinks over a period of time. Blinks are automatically detected the average blinks per minute and blinks interval are calculated.

8 All features accessible on just one screen Tear film breakup time analysis Dry eye syndrome is a growing public health concern causing visual disturbance due to tear film instability. The CA-800 offers a comprehensive analysis of the tear film by using the Blink detection and Tear Breakup Time measuring modes. Blink detection The Blink detection records the patient blinks over a period of time. Blinks are automatically detected the average blinks per minute and blinks interval are calculated. The summary of the Blink analysis includes: IBI Average: average Inter-Blink Interval, used to calculate the Ocular Protection Index (OPI) IBI standard deviation: standard deviation of the Inter-Blink Interval values Duration: total duration of the time range analyzed Blink/min: average number of blinks per minute Tear Breakup Time The Tear Breakup Time (TBT) records the patients tear film condition while they hold their blink and calculates the time of first breakup and average time for breakup of the Tear Film. This new feature allows video playback with a colored overlay to show the quality of the corneal surface. The TBT displays statistics and graphical data related to the Tear Film condition for the selected TBT acquisition. The sectors will be color-coded from green to red according to the scale on the left side of the image, showing the breakup overtime of the Tear Film. Acquisition stops automatically when a second blink is detected. 8

parameters for the connections to the available DICOM

9 DICOM Compliance The DICOM panel in the CA-800 connectivity section allows the user to set the needed parameters for the connections to the available DICOM features: Modality Worklist Patient Root Query Storage Storage Commitment 9

IMAGEnet 6 Compliance IMAGEnet 6 viewer software IMAGEnet 6 is Topcon s web based digital software platform for ophthalmic imaging, capable of acquiring, displaying, enhancing, analyzing, and saving

10 IMAGEnet 6 Compliance IMAGEnet 6 viewer software IMAGEnet 6 is Topcon s web based digital software platform for ophthalmic imaging, capable of acquiring, displaying, enhancing, analyzing, and saving digital images and reports obtained with a variety of Topcon devices such as the CA-800. IMAGEnet 6 provides flexibility of viewing Biometry, Keratometry, Pupillometry data and all available CA-800 exported reports in a network environment. There are a variety of software configurations available. Additional components can be added according to your clinic s needs. Screenshot of Biometry data in IMAGEnet 6 10

Reports Topography TOPCON Patient Information Patient TOPCON EUROPE MEDICAL Gender F Patient ID 123456789 Exam Date 14/08/2017 14:33:17 Date of Birth 01/01/1900 Surgeon TOPOGRAPHICAL MAP OD OS D

15 mm Cornea Decentralization X - Y 0.43 mm -0.14 mm Diameter 12.33 mm Diameter 12.19 mm Pupillar Decentralization X - Y H= -0.25 mm V= 0.06 mm Pupillar Decentralization X - Y H= 0.36 mm V= -0.

11 Reports Topography TOPCON Patient Information Patient TOPCON EUROPE MEDICAL Gender F Patient ID Exam Date 14/08/ :33:17 Date of Birth 01/01/1900 Surgeon TOPOGRAPHICAL MAP OD OS D Normalized - Axial D Normalized - Axial Sim-K K1 K2 CYL K1 K2 CYL D ax D ax171 Cornea Data Cornea Decentralization X - Y mm mm Cornea Decentralization X - Y 0.43 mm mm Diameter mm Diameter mm Pupillar Decentralization X - Y H= mm V= 0.06 mm Pupillar Decentralization X - Y H= 0.36 mm V= mm Avg. Pupillar Diam mm Avg. Pupillar Diam mm Avg. Pupillar Power 4.5mm: D / 3mm: D Avg. Pupillar Power 4.5mm: D / 3mm: D Keratoconus Screening AK AGC SI Kpi AK AGC SI Kpi D 0.71 D/mm D 0% D 0.67 D/mm 0.27 D 0% Topography not compatible with keratoconus Topography not compatible with keratoconus A D Ro - Teta Rnd A D Ro - Teta Rnd Keratorefractive Indices SD SAI e Kc SD SAI e Kc SD = 0.48 D SAI = 0.30 D e = SD = 0.37 D SAI = 0.16 D e = Notes CORNEAL_MAP (V ) 2017/08/15 10:42:32 11

12 12 Reports Pupillometry

13 Reports Zernike analysis 13

14 14 Reports Contact lens fitting

15 Reports Tear film breakup time 15

16 VISIA Imaging S.r.l. Specifications Keratoscope cone 24 rings equally distributed on a 43D sphere Analysed points Over 100,000 Measured points Over 6,200 Corneal coverage Diopter power range Resolution Accuracy / Precision axial radius Capture system Output ports Monitor Database Pupillometry Fluorescein Report Working environment Power source Power consumption Dimensions Connections Printing options Operating System RAM Hard Disk Up to 9,8mm on a sphere of radius 8,00mm (42,2 diopters with N=1.3375) From 1D to 120D ± 0.01D, 1 micron ± 0.03mm altimetric data +/- 2µm at 4mm Auto-focus with auto-capture USB, LAN LCD 10,1 inch capacitive touch screen Internal Dynamic, Photopic, Mesopic, Scotopic Image, Video Corneal map, Comparison map, Contact lens, Height map, Zernike analysis, Pupillometry, Toric IOL, Screenshot, Meibomian glands, Tear Film Breakup Time C, Relative humidity 30-75% (no dewing), Atmospheric pressure hPa AC V Hz <100VA 320mm (W) x 490mm (H) x 470mm (L), 15 Kg Wi-Fi Optional, LAN integrated USB printer, Network printer, PDF on network shared folder, PDF on USB Windows 7 Embedded 2 GB 320 GB IMPORTANT Subject to change in design and/or specifications without advanced notice. In order to obtain the best results with this instrument, please be sure to review all user instructions prior to operation. Medical device Class IIa. Manufacturer: VISIA imaging S.r.l. Topcon Europe Medical B.V. Essebaan 11; 2908 LJ Capelle a/d IJssel; P.O. Box 145; 2900 AC Capelle a/d IJssel; The Netherlands Phone: +31-(0) ; Fax: +31-(0) medical@topcon.eu; Topcon España S.A. HEAD OFFICE; Frederic Mompou, 4; Sant Just Desvern; Barcelona, Spain Phone: ; Fax: medica@topcon.es; Topcon Deutschland GmbH Hanns-Martin-Schleyer Strasse 41; D Willich, Germany Phone: (+49) ; Fax: (+49) info@topcon-medical.de; Topcon Ireland Unit 276, Blanchardstown; Corporate Park 2 Ballycoolin; Dublin 15, Ireland Phone: ; Fax: medical@topcon.ie; Topcon Danmark Praestemarksvej 25; 4000 Roskilde, Danmark Phone: ; Fax: info@topcon.dk Topcon Scandinavia A.B. Neongatan 2; P.O. Box 25; Mölndal, Sweden Phone: +46-(0) ; Fax: +46-(0) medical@topcon.se; Topcon Italy Viale dell Industria 60; Paderno Dugnano, (MI) Italy Phone: ; Fax: info@topcon.it; Topcon France BAT A1; 3 route de la révolte, Saint Denis Cedex Phone: +33-(0) ; Fax: +33-(0) topcon@topcon.fr; Topcon Polska Sp. z o.o. ul. Warszawska 23; Siewierz; Poland Phone: +48-(0) ; Fax: +48-(0) Topcon (Great Britain) Ltd. Topcon House; Kennet Side; Bone Lane; Newbury Berkshire RG14 5PX; United Kingdom Phone: +44-(0) ; Fax: +44-(0) medical@topcon.co.uk, Item code: / printed in Europe TOPCON EUROPE MEDICAL B.V. Essebaan 11, 2908 LJ Capelle a/d IJssel, The Netherlands Phone: +31-(0) , Fax: +31-(0) , medical@topcon.eu,

CA-800 Corneal Analyzer

CA-800 Corneal Analyzer CA-800 - Fully featured CA-800 - Corneal Analyzer Ease of use The CA-800 is extremely easy to handle and use. From image acquisition to analysis, the on-board software is intuitive